FibriCheck Data Registry

NCT06282393 | Recruiting

• 1 other identifier: Z-2023072
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.

Conditions

Cardiac Arrhythmia

Keywords

Photoplethysmography; Single-lead electrocardiography

Outcome Measures

Primary Outcomes (1)

• Alignment PPG measurement

  ECG-PPG alignment (RR-intervals)

  14 days

Study Arms (1)

FibriCheck recordings

OTHER

Device: FibriCheck recordings

Interventions

FibriCheck recordings DEVICE

PPG and single-lead ECG measurements

FibriCheck recordings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Access to a smartphone to perform daily measurements
• Ability to understand Dutch
• Atrial Fibrillation diagnosis OR one of the following:
• CHA2DS2-VASc score ≥2 (male) or ≥3 (female)
• Underwent elective cardiac surgery
• Known with:
• Chronic obstructive pulmonary disease
• Obstructive sleep apnea
• Heart Failure
• Hypertension
• Previous stroke or transient ischaemic attack
• Having palpitations and/or racing heart as symptoms
• Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)

You may not qualify if:

• Individuals which are currently in follow-up with their physician, using the FibriCheck application
• Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
• Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
• Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
• Persons that have a disability to perform the measurements according to the instructions for use
• Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

Sponsors & Collaborators

• Qompium NV: lead

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pieter Vandervoort, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Grieten, PhD

CONTACT

+3211485953; lars.grieten@fibricheck.com

Annelies Geeraerts, PhD

CONTACT

+3211485953; Annelies.Geeraerts@fibricheck.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 28, 2024
• Study Start: January 31, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

BE (1)